Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Safety and Efficacy of CDB-2914 for Emergency Contraception

27. august 2021 opdateret af: HRA Pharma

A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex

The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1623

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Jose, California, Forenede Stater, 95126
        • Planned Parenthood of Mar Monte
    • Colorado
      • Denver, Colorado, Forenede Stater, 80203
        • Planned Parenthood of the Rocky Mountains
    • Florida
      • Miami, Florida, Forenede Stater
        • Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
      • Pembroke Pines, Florida, Forenede Stater
        • Planned Parenthood of South Palm Beach, Pembroke Pines
    • Indiana
      • Bloomington, Indiana, Forenede Stater
        • Planned Parenthood of Indiana
    • Iowa
      • Ames, Iowa, Forenede Stater
        • Planned Parenthood of Greater Iowa
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Planned Parenthood of Maryland
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Planned Parenthood League of Massachusetts
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
        • Planned Parenthood of Mid-Michigan Alliance
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater
        • Planned Parenthood of Minnesota
    • Ohio
      • Cleveland, Ohio, Forenede Stater
        • Planned Parenthood of Greater Cleveland
    • Oregon
      • Portland, Oregon, Forenede Stater, 97206
        • Planned Parenthood of Columbia-Willamette
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater
        • Planned Parenthood of SE Philadelphia
    • Texas
      • Austin, Texas, Forenede Stater
        • Planned Parenthood of the Texas Capital Region
      • Houston, Texas, Forenede Stater, 77004
        • Planned Parenthood of Houston and Southeast Texas
    • Utah
      • Salt Lake City, Utah, Forenede Stater
        • Planned Parenthood Association of Utah
    • Washington
      • Seattle, Washington, Forenede Stater, 98122
        • Planned Parenthood of Western Washington

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Aged 18 years or more
  • Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
  • Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
  • No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
  • For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
  • Willing to not use hormonal methods of contraception until study completion
  • At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
  • Able to provide informed consent in English
  • Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks)
  • Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained

Exclusion Criteria:

  • One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
  • All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
  • Currently pregnant as confirmed by positive HSUP test performed at screening
  • Currently breast-feeding
  • Current use of hormonal contraception
  • Use of hormonal emergency contraception since last menstrual period
  • Current use of IUD
  • Tubal ligation
  • Partner with a vasectomy
  • Unsure about the date of the last menstrual period
  • Severe asthma insufficiently controlled by oral glucocorticoid
  • Currently enrolled in any other trial of an investigational medicine

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CDB-2914
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
Medicin: CDB-2914

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pregnancy Rate
Tidsramme: Up to 60 days after enrollment

A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points:

  • 5-7 days after expected date of menses
  • 1 week later
  • every two week after
Up to 60 days after enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
Tidsramme: within the menstrual cycle of the unprotected Intercourse
Number of prevented pregnancies divided by the number of expected pregnancies
within the menstrual cycle of the unprotected Intercourse
Impact on Menstrual Bleeding Patterns
Tidsramme: within the menstrual cycle of the unprotected Intercourse
Menstrual cycle length post treatment
within the menstrual cycle of the unprotected Intercourse
Frequencies of Subjects With Treatment Emergent Adverse Events
Tidsramme: 12-14 days after expected menses
Most common related adverse events in ITT population.
12-14 days after expected menses

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

HRA Pharma

Efterforskere

  • Ledende efterforsker: Paul Fine, MD, Planned Parenthood of Houston and Southeast Texas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2006

Primær færdiggørelse (Faktiske)

8. april 2008

Studieafslutning (Faktiske)

5. juni 2009

Datoer for studieregistrering

Først indsendt

13. december 2006

Først indsendt, der opfyldte QC-kriterier

13. december 2006

Først opslået (Skøn)

14. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2914-005

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Nødprævention

Kliniske forsøg med CDB-2914

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Iran

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner